Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of OTREXUP ™, the first U.S. Food and Drug Administration (FDA) approved subcutaneous (SC) methotrexate (MTX) product for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP was approved by the FDA in October 2013. OTREXUP is available at distribution centers throughout the USA. Approximately 1.3 million Americans are diagnosed with RA and about 7.5 million with psoriasis. Initial treatment of these conditions with oral MTX usually provides a good response for many patients. However, some patients find it difficult to tolerate the oral formulation and/or receive limited benefit, especially when higher doses are required for a satisfactory response. Absorption following oral dosing showed a plateau effect at doses of 15 mg and greater. “OTREXUP provides an attractive new option that may benefit patients who have had an inadequate response to or are intolerant of oral MTX,” said Paul K. Wotton, PhD, President and Chief Executive Officer, Antares. “OTREXUP is an easy-to-use auto injector that delivers greater blood levels of medication than oral MTX. OTREXUP could extend the use and benefits of MTX and potentially delay or avoid the use of other more expensive treatment options in some patients.” OTREXUP is indicated for adults with severe active rheumatoid arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs), and children with active polyarticular juvenile idiopathic arthritis (pJIA). OTREXUP also is indicated for use in adults who need symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy. “CreakyJoints welcomes new treatment options for patients with RA,” said Seth Ginsberg, president and co-founder of CreakyJoints, one of the nation’s largest rheumatic disease patient advocacy groups. “Because so many RA patients have limited manual dexterity, conventional syringes for injection of methotrexate are often difficult to use. An easy delivery system that combines subcutaneous methotrexate with a pre-filled auto-injector is an important addition to treatment options available because it expands RA patients’ access to care.”
The injectable use of MTX after an inadequate response to oral MTX is quite common in Europe and elsewhere in the world. In the United States, however, use of injectable MTX is often overlooked primarily due to the challenges of self-injection. The fear of needles, poor manual dexterity, especially in people living with RA, and a lack of confidence in accurately and safely self-injecting with a vial, needle and syringe may be some of the challenges people have to face.“OTREXUP is a useful new treatment option that physicians can consider for their patients who could continue to benefit from MTX when their tablets provide an inadequate response,” said Alvin F. Wells, MD, PhD, Director, Rheumatology & Immunotherapy Center, located in Franklin, Wisconsin. “An easy-to-use and almost pain-free injection can provide the higher blood levels of medication that may be necessary for these patients.” “Antares is committed to the consistent availability of OTREXUP and the support that patients and healthcare providers need,” said LeRoux Jooste, SVP and General Manager, Antares Pharmaceuticals. “We have shipped OTREXUP to distribution centers throughout the US and have ample inventory of OTREXUP available to supply the market. As a research and development company, we plan ahead to ensure that OTREXUP remains an available treatment option for the patients who need it.” For full prescribing information please visit WWW.OTREXUP.COM. Important Safety Information Otrexup is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:
- Treat certain adults with severe active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs) have been used and did not work well
- Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well
Methotrexate includes the following boxed warning:Otrexup can cause serious side effects that can lead to death, including:
- Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or rheumatoid arthritis have an increased risk of death from organ toxicity. Types of organ toxicity can include gastrointestinal, bone marrow, liver, immune system, nerve, lung, kidneys, and skin.
- Women who are pregnant are at increased risk for death of the baby and for birth defects in the baby. Women who are pregnant or who plan to become pregnant must not take Otrexup. A pregnancy test should be performed before starting Otrexup.
- For a minimum of 3 months after treatment with Otrexup for males.
- During and for at least 1 menstrual cycle after treatment with Otrexup for females.
- Fertility problems. Methotrexate, the active ingredient in Otrexup, may affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes to their menstrual cycle. This can happen while taking Otrexup and for a short period of time after you stop.
- Certain cancers. Some people who have taken methotrexate have had a certain type of cancer called Non-Hodgkin’s lymphoma and other tumors. Your doctor may tell you to stop taking Otrexup if this happens.
- Tissue and bone problems. Taking methotrexate while having radiation therapy may increase the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone.
Who should not take Otrexup?Do not take Otrexup if you:
- Are pregnant or planning to become pregnant
- Are breastfeeding; Otrexup can pass into your breast milk and may harm your baby
- Have alcohol problems (alcoholism)
- Have liver problems
- Have problems fighting infection (immunodeficiency syndrome)
- Have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anemia), or platelets
- Have had an allergy to methotrexate or any of the ingredients in Otrexup